GlaucoCetin for Glaucoma

Overseen By Jeanne Molineaux, COA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wills Eye

Must not be taking: Antiseizure, Antiplatelet, Anticoagulants, others

Disqualifiers: Epilepsy, Uncontrolled hypertension, Diabetes, others

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a daily supplement called GlaucoCetin, which aims to help people with open angle glaucoma. The supplement is designed to protect and support the nerve cells in the eye that are crucial for vision. Researchers want to see if taking GlaucoCetin over several months can improve vision and overall quality of life for these patients.

Will I have to stop taking my current medications?

The trial requires that you stop using certain medications and supplements, such as Biotin, Ginkgo Biloba, and Citicoline, at least 3 months before starting. If you are on systemic steroids, immunomodulating agents, or certain blood thinners, you may not be eligible to participate.

Is GlaucoCetin safe for humans?

The safety of glaucoma medications, including their side effects and potential for causing discomfort, is an important consideration. These medications can cause changes to the eye's surface and may have systemic effects (affecting the whole body) due to absorption through the eye and nose. It's important for patients to be informed about possible side effects and how to manage them. ^{1 2 3 4 5}

How is the drug GlaucoCetin different from other glaucoma treatments?

GlaucoCetin is unique because it is being tested against a placebo to understand its effectiveness in treating glaucoma, which is a novel approach as most existing treatments focus on lowering intraocular pressure through established drugs or procedures. This trial may provide insights into new mechanisms or benefits that are not yet available with current therapies. ^{5 6 7 8 9}

Research Team

Natasha N Kolomeyer, MD

Principal Investigator

Wills Eye Hospital

Eligibility Criteria

This trial is for people aged 40-80 with open-angle glaucoma, controlled eye pressure, and good visual acuity. Participants must have specific types of visual field defects but no other significant eye diseases or recent surgeries. They shouldn't be on certain medications like nitroglycerin or anti-seizure drugs, nor should they have uncontrolled blood pressure or diabetes.

Inclusion Criteria

Age of 40 to 80 years

Group 2 (Central): at least 1 paracentral point repeatedly depressed at p<1% on 24-2. Also meets the HAP criteria outlined above.

Intraocular Pressure (IOP) controlled at 2 measurements >3 months

Exclusion Criteria

You are currently using nitroglycerin medication.

You have an eye condition that could make it difficult to accurately measure your eye pressure.

Visually significant retinal pathology affecting vision in past or active (such as diabetic retinopathy or age related macular degeneration)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either GlaucoCetin or placebo for 6 months to evaluate changes in vision and visual function

6 months

Multiple visits for visual field testing, OCT, and other assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• GlaucoCetin
• Placebo

Trial Overview The study tests GlaucoCetin, a medical food designed to protect optic nerve cells in glaucoma patients against a placebo over six months. Patients are randomly chosen to receive either the treatment or placebo to see if there's an improvement in vision.

Participant Groups

Group I: GlaucoCetin Peripheral Group Active Control 1 Intervention

Primary Open Angle Glaucoma participants who meet inclusion exclusion criteria with peripheral visual field loss will be randomly assigned GlaucoCetin, a medical food in capsule form.

Group II: GlaucoCetin Central Group Active Control 1 Intervention

Primary Open Angle Glaucoma participants who meet inclusion exclusion criteria with central visual field loss will be randomly assigned GlaucoCetin, a medical food in capsule form.

Group III: Placebo Peripheral Group Placebo Group 1 Intervention

Primary Open Angle Glaucoma participants who meet inclusion exclusion criteria with peripheral visual field loss will be randomly assigned a placebo, with no nutritional value, in capsule form.

Group IV: Placebo Central Group Placebo Group 1 Intervention

Primary Open Angle Glaucoma participants who meet inclusion exclusion criteria with central visual field loss will be randomly assigned a placebo, with no nutritional value, in capsule form.

Who Is Running the Clinical Trial?

Wills Eye

Lead Sponsor

Trials

81

Recruited

15,400+

Guardian Health Sciences, Inc.

Collaborator

Trials

1

Recruited

100+

Findings from Research

In a study involving 3,333 glaucoma patients, 79% reported satisfaction with their topical glaucoma medications, indicating a high level of acceptance among users.

The most commonly prescribed medications, including timolol and latanoprost, showed comparable tolerability, with only a 9% chance of patients needing to change their medication due to side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Side effects of commonly used glaucoma medications: comparison of tolerability, chance of discontinuation, and patient satisfaction. Beckers, HJ., Schouten, JS., Webers, CA., et al.[2021]

The safety profile of glaucoma medications is crucial for treatment adherence, as side effects can lead to patients not following their prescribed therapy.

Long-term use of glaucoma eyedrops, especially those with preservatives, can cause ocular surface changes and systemic effects, highlighting the need for careful selection of medications and patient education on potential side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Side effects of glaucoma medications. Detry-Morel, M.[2018]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Side effects of commonly used glaucoma medications: comparison of tolerability, chance of discontinuation, and patient satisfaction. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Microbial contamination of medications used to treat glaucoma. [2022]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Safety comparison of additives in antiglaucoma prostaglandin (PG) analog ophthalmic formulations. [2021]

4. Belgium pubmed.ncbi.nlm.nih.gov

Side effects of glaucoma medications. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Are Patient Self-Reported Outcome Measures Sensitive Enough to Be Used as End Points in Clinical Trials?: Evidence from the United Kingdom Glaucoma Treatment Study. [2020]

6. England pubmed.ncbi.nlm.nih.gov

The placebo effect in early-phase glaucoma clinical trials. [2015]

7. Germany pubmed.ncbi.nlm.nih.gov

[Drug therapy of glaucoma]. [2006]

8. England pubmed.ncbi.nlm.nih.gov

Latanoprost for open-angle glaucoma (UKGTS): a randomised, multicentre, placebo-controlled trial. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Topical treatment of glaucoma: established and emerging pharmacology. [2021]